On April 28, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that its abstract has been accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place online from 4-8 June 2021 (Press release, BerGenBio, APR 28, 2021, View Source [SID1234578636]).

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Abstract titles have been announced online at View Source and details of the presentation are below. Full abstracts will be published on the ASCO (Free ASCO Whitepaper) website on 19 May 2021.

Title: Ph I/II study of oral selective AXL inhibitor bemcentinib (BGB324) in combination with erlotinib in patients with advanced EGFRm NSCLC: End of trial update

Session Title: Lung Cancer – Non-Small Cell Metastatic

Abstract ID: 9110

Date/Time: Friday, June 4, 2021 at 9:00 AM (EDT)

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor to ACE2, to which the spike protein of the Sars-Cov-2 virus attaches and enters the host cell, and AXL expression is upregulated that leads to suppression of the Type 1 Interferon immune response by host cells and in their environment. Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and promotes the anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers. AXL suppresses the body’s immune response to tumours and drives treatment failure across many cancers. High AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib, therefore, have potential high value as monotherapy and as the cornerstone of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases including fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent and highly selective AXL inhibitor, currently in a broad phase II clinical development programme. It is administered as an oral capsule and taken once per day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity.

On April 28, 2021 Alkermes plc (Nasdaq: ALKS) reported financial results for the first quarter of 2021 (Press release, Alkermes, APR 28, 2021, View Source [SID1234578653]).

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"Our first quarter results reflect solid execution against our strategy to grow revenues and actively manage our cost structure. As the country begins to see signs of recovery from the pandemic, we believe we are well-positioned to efficiently manage our business and to achieve our long-term profitability targets," commented Iain Brown, Chief Financial Officer of Alkermes. "Today, we are reiterating our financial expectations for 2021, as we continue to position VIVITROL and ARISTADA for long-term growth, prepare for the anticipated launch of LYBALVI, advance the clinical development program for nemvaleukin and invest in our neuroscience and oncology development pipeline."

Quarter Ended March 31, 2021 Financial Results

Revenues

Total revenues for the quarter were $251.4 million. This compared to $246.2 million for the same period in the prior year.
Net sales of proprietary products for the quarter were $130.0 million, compared to $129.7 million for the same period in the prior year.
Net sales of VIVITROL were $74.5 million, compared to $78.8 million for the same period in the prior year, representing a decrease of approximately 5%, primarily due to COVID-19-related disruptions.
Net sales of ARISTADAi were $55.4 million, compared to $51.0 million for the same period in the prior year, representing an increase of approximately 9%.
Manufacturing and royalty revenues for the quarter were $119.8 million, compared to $116.3 million for the same period in the prior year.
Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $75.7 million, compared to $82.2 million for the same period in the prior year.
Manufacturing and royalty revenues from VUMERITY were $13.4 million, compared to $1.7 million for the same period in the prior year.
Costs and Expenses

Total operating expenses for the quarter were $267.9 million, compared to $283.6 million for the same period in the prior year.
Cost of Goods Manufactured and Sold were $41.0 million, compared to $47.2 million for the same period in the prior year.
Research and Development (R&D) expenses were $92.3 million, compared to $93.3 million for the same period in the prior year.
Selling, General and Administrative (SG&A) expenses were $125.2 million, compared to $133.4 million for the same period in the prior year.
Profitability

Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $22.4 million for the quarter, or a basic and diluted GAAP loss per share of $0.14. This compared to GAAP net loss of $38.7 million, or a basic and diluted GAAP loss per share of $0.24, for the same period in the prior year.
Non-GAAP net income was $17.8 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.11. This compared to non-GAAP net income of $1.7 million, or a non-GAAP basic and diluted earnings per share of $0.01 for the same period in the prior year.
Balance Sheet

At March 31, 2021, the company recorded cash, cash equivalents and total investments of $627.4 million, compared to $659.8 million at Dec. 31, 2020, driven primarily by the company’s operating results and changes in working capital. The company’s total debt outstanding as of March 31, 2021 was $297.7 million, following the March 2021 refinancing of the company’s term loan, which extended its maturity date to March 2026.
Financial Expectations for 2021

Alkermes reiterates its financial expectations for 2021, and the assumptions underlying such expectations, as set forth in its press release dated Feb. 11, 2021.

"We are intensely focused on increasing Alkermes’ value through the combination of scientific and business excellence. The first few months of 2021 were highlighted by important advancements in our nemvaleukin immuno-oncology program, including receipt of orphan drug designation for mucosal melanoma, initiation of ARTISTRY-6, a phase 2 trial to further evaluate nemvaleukin’s monotherapy utility in melanoma, entry into a clinical trial and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) in platinum-resistant ovarian cancer, and achievement of the first partial response in platinum-resistant ovarian cancer in the ARTISTRY-2 subcutaneous dosing study. At our recent Investor Day, we also introduced new assets from our pipeline, including our CoREST-selective HDAC inhibitor program, our orexin 2 receptor agonist program and our platform of engineered cytokines, including our tumor-targeted, split IL-12 fusion protein," said Richard Pops, Chief Executive Officer of Alkermes. "Coupled with expected growth of our commercial portfolio, including the potential launch of LYBALVI and growth of VUMERITY, and a focus on efficiency, cost management and strong governance, we have the potential to drive significant growth and value creation in 2021 and beyond."

Recent Events:

Nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230)

In March 2021, nemvaleukin, the company’s investigational engineered interleukin-2 (IL-2) variant immunotherapy, was granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA).
In April 2021, the company entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) for a planned phase 3 study to evaluate nemvaleukin in combination with KEYTRUDA (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer. The study is planned to initiate in the second half of 2021.
In April 2021, the company initiated ARTISTRY-6, a global phase 2 study evaluating the anti-tumor activity, safety and tolerability of intravenous nemvaleukin monotherapy in patients with mucosal melanoma. The study also includes a cohort of patients with advanced cutaneous melanoma who will receive subcutaneous (SC) nemvaleukin with intent to establish monotherapy proof-of-concept with SC dosing.
Psychiatry

In April 2021, the company presented new research from its psychiatry portfolio at the 2021 Congress of the Schizophrenia International Research Society (SIRS), which took place virtually April 17-21, 2021. The company’s presentations included new exploratory analyses from its phase 3 ENLIGHTEN-2 study of LYBALVI.
Corporate

In March 2021, Alkermes held a virtual Investor Day to discuss the company’s research and development strategy and portfolio, including updates from its nemvaleukin development program and introduction of new preclinical neuroscience and immuno-oncology programs. The company also provided an update on the implementation of its Value Enhancement Plan announced in December 2020.
Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, April 28, 2021, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, April 28, 2021, through Wednesday, May 5, 2021, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13718854.

On April 28, 2021 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases , reported its financial results for the quarter ended March 31, 2021 (Press release, AC Immune, APR 28, 2021, View Source;oq=AC+Immune+Reports+First+Quarter+2021+Financial+Results+and+Provides+Corporate+Update&aqs=chrome..69i57j69i61.671j0j7&sourceid=chrome&ie=UTF-8 [SID1234578674]). The Company also provided an overview of its recent clinical and corporate highlights and anticipated milestones for 2021.

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Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Our clinical and R&D accomplishments over the last quarter serve to strengthen our leadership in precision medicine for neurodegenerative diseases. Encouraging clinical results from both of our Alzheimer’s vaccine programs further reinforce our belief that early intervention, and ultimately prevention, using vaccines represents a key strategy in neurodegenerative diseases. To enable this strategy, we are advancing our suite of novel diagnostics, such as our alpha-synuclein imaging agent, which recently entered the clinic in Parkinson’s disease. Our vision is to address the heterogeneity of neurodegenerative diseases by pairing earlier, more accurate diagnosis with highly selective treatments that address the right proteinopathy, in the right patient, at the right time."

Prof. Pfeifer continued: "We are poised to achieve four additional clinical readouts in 2021, as we continue progressing our first-in-class preclinical programs addressing alpha-synuclein, TDP-43, and NLRP3-ASC towards the clinic, driving significant future value creation.

Q1 2021 Highlights

Clinical and R&D

Reported encouraging top line results from a first-of-its-kind Phase 1b study of anti-Abeta vaccine candidate ACI-24 in people with Down syndrome (DS). These results support further development in Down syndrome-related Alzheimer’s disease (AD). AC Immune also reported promising preclinical results for an optimized anti-Abeta vaccine formulation, for which it expects to file an investigational new drug application (IND) in Q4 2021.
Reported promising interim Phase 1b/2a results for ACI-35.030, a novel anti-phospho-Tau (pTau) vaccine candidate, showing strong safety and high titers of antigen-specific antibodies in 100% of older patients with early Alzheimer’s disease. The study is currently enrolling patients into the highest dose group, with further clinical readouts expected this year.
Advanced next-generation alpha-synuclein positron emission tomography (PET) tracer candidate, ACI-12589, into a first-in-human clinical study, with an expected data readout in Q3 2021
Identified and characterized the first biologically active small molecule Morphomer alpha-synuclein aggregation inhibitors, which significantly decreased alpha-synuclein aggregate formation in cellular assays by interfering with the fibrillation process
Reported key advancements for several therapeutic programs targeting the (NOD)-like receptor protein 3 (NLRP3) inflammasome, including small molecule inhibitors, which showed the first evidence of in vivo activity in a model of peripheral inflammation, as well as high-affinity monoclonal antibodies that bind extracellular components of the NLRP3 pathway and inhibit inflammasome-mediated immune response in vitro
Thought leadership

Co-sponsored a virtual Global Down Syndrome Forum that brought together thought leaders on Down syndrome and Down syndrome-related Alzheimer’s disease to discuss the unmet need and underlying causes of this important health challenge, as well as the broader implications for clinical development in other Alzheimer’s disease populations.
Hosted a comprehensive webinar focusing on the Company’s proprietary Morphomer platform underlying the generation of therapeutic and diagnostic small molecules, which featured presentations and a Q&A session with members of AC Immune’s Management and R&D Teams.
Strengthening of Board

Welcomed Dr. Alan Colowick, an experienced biotech and investment executive, to the Company’s Board of Directors

Achieved and Anticipated 2021 milestones

Clinical Milestones

ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a in AD interim results in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)
JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose)
Alpha-synuclein PET imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; readout expected in Q3
ACI-24 anti-Abeta vaccine in DS: reported Phase 1b top line results in Q1; to present further study results at the Alzheimer’s Association International Conference 2021 in Q3
ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2
Semorinemab anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in moderate AD in Q2
ACI-3024 small molecule MorphomerTM Tau aggregation inhibitor: select NeuroOrphan indication for further development in Q2
ACI-24 in DS: submit investigational new drug (IND) application for optimized vaccine formulation in Q4
Preclinical Milestones

Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q3
TDP-43 imaging agent: initiate investigational new drug (IND)-enabling studies in Q3
Morphomer NLRP3-ASC: report in vivo proof-of-concept results in a non-central nervous system (CNS) disease model and begin in vivo proof-of-concept studies with validated candidate in CNS in Q4
Anti-NLRP3-ASC antibody: begin in vivo proof-of-concept studies in Q4
Anti-TDP-43 antibody: initiate IND-enabling toxicology studies in Q4
TDP-43 biofluid diagnostic: establish validation-ready assay in Q4
Therapeutic and Diagnostic Pipeline Overview

On March 23, 2021, the Company provided a comprehensive overview highlighting strong progress across its clinical and preclinical development pipeline. This supplemental material can be viewed and downloaded in the investor section of the Company’s website.

Analysis of Financial Statements for the quarter ended March 31, 2021

Cash Position: The Company had a total cash balance of CHF 216.1 million, composed of CHF 151.1 million in cash and cash equivalents and CHF 65 million in short-term financial assets. This compares to a total cash balance of CHF 225.9 million as of December 31, 2020. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without potential incoming milestone payments.
Contract Revenues: The Company did not record contract revenues for the three months ended March 31, 2021, a decrease of CHF 12.3 million from the comparable period. The decrease is predominantly related to a CHF 10 million milestone payment as well as CHF 2.1 million in R&D activities recognized in 2020, which did not repeat.
R&D Expenditures: R&D expenses decreased by CHF 1.9 million for the three months ended March 31, 2021 to CHF 13.3 million.
Discovery and preclinical expenses (+1.2 million): The Company increased expenditures across a variety of its discovery and preclinical programs. These include investments to advance the optimized formulation of our ACI-24 vaccine, the expansion of our Morphomer Tau program into NeuroOrphan indications and various other investments across our programs.
Clinical expenses (-4.1 million): The Company decreased expenditures across multiple clinical programs, as certain clinical activities completed or incurred significant scaling up in the prior period. For example, the Company completed its clinical activities to complete the Phase 1 trial of our Morphomer Tau asset in partnership with Lilly. Additionally, the Company incurred less expense for ACI-24 for DS-related AD as a result of prior period scaling up activities for a Phase 2 clinical trial which were not repeated in the current period.
Salary- and benefit-related costs (+1.1 million): The Company’s salary- and benefit-related costs increased primarily due to the internal reallocation of certain employees’ salaries and annualization of 2020 hires and increases in share-based compensation
G&A Expenditures: For the three months ended March 31, 2021, G&A decreased by CHF 0.2 million to 4.3 million. This decrease is predominantly related to the internal reallocation of certain employees’ salaries.
Other Operating Income: The Company recognized CHF 0.4 million in grant income for R&D activities performed under our MJFF and Target ALS grants, an increase of CHF 0.3 million compared to the prior period
IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 16.7 million for the three months ended March 31, 2021, compared with net loss of CHF 7.7 million for the comparable period in 2020
2021 Financial Guidance

For the full year 2021, the Company expects its total cash burn to range between CHF 65 million ‒75 million.

On April 28, 2021 Medivir AB reported that Interim Report January – March 2021 (Press release, Medivir, APR 28, 2021, View Source;interim-report-january–march-2021-301278700.html [SID1234578697]).

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Financing secured to bring the MIV-818 study into the next phase

January – March

Financial summary for the quarter

Net turnover amounted to SEK 9.9 (7.3) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -7.2 (-20.7) million. Basic and diluted earnings per share amounted to SEK -0.18 (-0.96) and SEK -0.18 (-0.96) respectively.
Cash flow from operating activities amounted to SEK -1.5 (-16.6) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 269.3 (116.6) million.
Significant events during the quarter

In January the company signed an exclusive license agreement with IGM Biosciences, Inc. for birinapant. Medivir received a payment of USD 1 million after signing, which is to be followed by an additional USD 1.5 million when IGM includes birinapant in phase I clinical trials. In addition, the agreement entitles Medivir to milestone payments and royalties.
A rights issue of class B shares with preferential rights for existing shareholders was completed in early February. Through the rights issue, which was oversubscribed to 93.5 percent, Medivir received approximately SEK 170 million before transaction costs.
The Board of Directors decided to exercise the over-allotment option of SEK 25 million, directed to the specialist investor HealthInvest.
An Extraordinary General Meeting on March 11, 2021, decided on a directed new share issue of approximately SEK 28 million to Linc AB.
In February 2021 a licensing agreement with Ubiquigent was signed for the preclinical research program USP7.
In March, the last patient was included in the first part of the phase Ib study with MIV-818.
In March 2021, it was announced that Yilmaz Mahshid will leave his position as CEO of Medivir at the Annual General Meeting on May 5, for personal reasons. The recruitment process for a new CEO has begun.
Medivir’s Nomination Committee proposes the re-election of Uli Hacksell, Lennart Hansson, An van Es Johansson and Bengt Westermark as board members. The Nomination Committee proposes the election of Yilmaz Mahshid as new board member and that Uli Hacksell is elected Chairman of the Board.
Bengt Julander and Helena Levander have declined re-election.
Significant events after the end of the quarter

On April 16, it was announced that Magnus Christensen had been appointed interim CEO of Medivir. He will take up his new role in connection with Medivir’s Annual General Meeting on May 5, 2021.
On April 19, it was announced that the overall results from the first part of the phase Ib study with MIV-818 were positive with a good safety and tolerability profile. Thus, the starting dose for the second part of the phase Ib study could be determined.

Conference call for investors, analysts and the media
The Interim Report January – March 2021 will be presented by Medivir’s President & CEO, Yilmaz Mahshid.

The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.

On April 28, 2021 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that it will host an investor event to present updated data from its Phase 2 skin cancer cohorts combining RP1 with Opdivo and data from its Phase 1 study of RP2 alone and in combination with Opdivo (Press release, Replimune, APR 28, 2021, View Source [SID1234578745]). The event will include presentations by Philip Astley-Sparke, Chief Executive Officer of Replimune, Robert Coffin, Ph.D., President and Chief Research & Development Officer of Replimune, and Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Haematology Centre and Head of the Department of Oncology at the University of Oxford.

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The event will begin at 8:00 a.m. Eastern Time on Thursday, June 3, 2021. The webcast and slides will be accessible live under "Events & Presentations" on the Investors page of the Company’s website at www.replimune.com or by clicking here. A replay of the event will be available on Replimune’s website.

Opdivo (nivolumab) is a registered trademark of Bristol-Myers Squibb Company.